Abstract:

An assembly for measuring in vivo biomechanical properties of skin,
comprising a testing device, said testing device comprising; a first pad
attachable to the skin a second pad attachable to the skin, at a known
distance from the first pad; said attachability of the pads to the skin
to prevent relative movement between the respective pad and the skin to
which it is attached; a forcing means for applying a force to the first
pad, whilst said pads are attached to the skin, along a first axis
connecting the first and second pad, to induce a corresponding relative
movement between the pads due to deformation of the skin between said
pads; a force measurement device for measuring the applied force, and; a
displacement measurement device for measuring the corresponding induced
movement.

Claims:

1. An assembly for measuring in vivo biomechanical properties of skin,
comprising a testing device, said testing device comprising:a first pad
attachable to the skin;a second pad attachable to the skin, at a known
distance from the first pad, said attachability of the pads to the skin
to prevent relative movement between the respective pad and the skin to
which it is attached;a forcing means for applying a force to the first
pad, whilst said pads are attached to the skin, along a first axis
connecting the first and second pad, to induce a corresponding relative
movement between the pads due to deformation of the skin between said
pads; a force measurement device for measuring the applied force; anda
displacement measurement device for measuring the corresponding induced
movement.

2. The assembly according to claim 1, wherein the testing device further
includes a support bracket, such that the first pad is slidingly mounted
to the support bracket, and the second pad is fixedly mounted to the
support bracket, wherein the first pad is slidingly movable parallel to
the first axis.

3. The assembly according to claim 2, wherein the testing device further
includes a third pad attachable to the skin and fixedly mounted to the
support bracket along the first axis, so as to place the first pad
intermediate between the second and third pad.

4. The assembly according to claim 2, wherein the testing device further
includes a third pad attachable to the skin and fixedly mounted to the
support bracket, said third pad spaced from the first pad along a second
axis orthogonal to the first axis.

5. The assembly according to claim 1, wherein the forcing means includes a
constant strain rate actuator for selectively applying the force at a
predetermined strain rate of the skin.

6. The assembly according to claim 1, wherein the pads are attachable to
the skin using skin attachment means, said skin attachment means
including any one or a combination of adhesive material, double-sided
tape, clamps to clamp each pad to the skin and a strap for strapping each
pad to the skin.

7. The assembly according to claim 6 wherein the strap includes a spacer
placed beneath the pad between the strap and skin for concentrating a
skin attachment force at the pad.

8. The assembly according to claim 1, wherein the biomechanical properties
include any one or a combination of force-elongation characteristic, and
time-dependent force and strain characteristics.

9. The assembly according to claim 8, wherein a plurality of measurements
of applied force and corresponding induced movement in a plurality of
directions through a point is used to determine two-dimensional
biomechanical properties at said point.

10. The assembly according to claim 9, wherein the two dimensional
biomechanical properties include determining the direction of the
Langer's Line, through said point.

11. The assembly according to claim 3 wherein the fixed mounting of the
second and third pad to the support bracket is selectively adjustable to
permit sliding movement of said pads.

12. The assembly according to claim 1, further including a positioning
assembly having an engagement portion for engaging an external body and a
holding portion for holding the testing device, said positioning assembly
adapted to selectively support the weight of the testing device.

13. The assembly according to claim 12, wherein the holding portion
includes a constrained sliding engagement of the testing device.

14. The assembly according to claim 13, wherein the positioning assembly
is selectively deformable for positioning the testing device relative to
the skin.

15. The assembly according to claim 14, wherein said holding portion
includes a load measurement device to measure the force and torque
applied by the testing device to the skin.

16. The assembly according to claim 5, wherein the forcing means includes
a worm gear intermediate between the constant strain rate actuator and
the first pad.

17. The assembly according to claim 1, further including at least one
supporting pad attachable to the skin using the skin attachment means,
said supporting pad mounted to the supporting bracket, such that the at
least one pad is positionable to provide additional support to the
testing device on application of the applied force.

18. The assembly according to claim 1, wherein the ratio of pad width to
the known distance separating the first and second pads is at least 1.0.

19. The assembly according to claim 18, wherein the ratio is at least 2.5.

20. An assembly for measuring in vivo biomechanical properties of skin,
comprising a testing device, said testing device comprising:a first pad
array attachable to the skin;a second pad attachable to the skin, at a
known distance from the first pad array, said attachability of the pads
to the skin to prevent relative movement between the respective pad and
the skin to which it is attached;a forcing means for applying a force to
the first pad array, whilst said first pad array and second pads are
attached to the skin, along a first axis connecting the first pad array
and second pad, to induce a corresponding relative movement between a
portion of the first pad array and the second pad due to deformation of
the skin;a force measurement device for measuring a force between the
portion of the first pad array and the second pad as a result of the
applied force; anda displacement measurement device for measuring the
corresponding induced movement.

21. The assembly according to claim 20, wherein the portion of the first
pad array includes a sensor pad isolated from other pads forming the
first pad array.

22. The assembly according to claim 21, wherein the first pad array
further comprises at least two discreet pads placed peripheral to the
sensor pad, said forcing means mounted to the discreet pads.

23. The assembly according to claim 21, wherein the first pad array
further comprises a spreader pad of width greater than the sensor pad,
said sensor pad placed adjacent to the spreader pad and intermediate the
spreader pad and second pad, and said forcing means mounted to the
spreader pad.

24. The assembly according to claim 23, wherein said spreader pad is
C-shaped with the sensor pad located within a concave region of the C.

25. An assembly for measuring in vivo biomechanical properties of skin,
comprising a testing device, said testing device comprising:a first pad
attachable to the skin;a second pad attachable to the skin, at a known
distance from the first pad, said attachability of the pads to the skin
to prevent relative movement between the respective pad and the skin to
which it is attached;a forcing means for applying a force to the first
pad, whilst said pads are attached to the skin, along a first axis
orthogonal to a second axis connecting the first and second pad, to
induce a corresponding relative movement between the pads due to
deformation of the skin between said pads;a force measurement device for
measuring the applied force; anda displacement measurement device for
measuring the corresponding induced movement.

26. The assembly according to claim 25, wherein the testing device further
includes a support bracket, such that the first pad is slidingly mounted
to the support bracket, and the second pad is fixedly mounted to the
support bracket, wherein the first pad is slidingly movable parallel to
the first axis.

27. The assembly according to claim 25, wherein the biomechanical
properties include any one or a combination of shear force-elongation
characteristic, and time-dependent shear force and strain
characteristics.

28. A method for measuring in vivo biomechanical properties of skin,
comprising the steps of:attaching a first pad to the skin;attaching a
second pad to the skin, at a known distance from the first pad, said pads
attached to prevent relative movement between the respective pad and the
skin;applying a force to the first pad, along a first axis connecting the
first and second pad, to induce corresponding relative movement between
the pads to cause deformation of the skin between said pads;measuring the
applied force; andmeasuring the corresponding induced movement.

29. The method according to claim 28, further including the step of
attaching a third pad to the skin, co-linear with the first axis, so as
to place the first pad intermediate between the second and third pad.

30. The method according to claim 28, further including the step of
attaching a third pad to the skin, said third pad spaced from the first
pad along a second axis orthogonal to the first axis.

31. The method according to claim 28, wherein the step of applying the
force includes using a constant strain rate actuator for selectively
applying the force at a pre-determined strain rate of the skin.

32. The method according to claim 28, wherein the pads are attached to the
skin using skin attachment means, said skin attachment means including
any one or a combination of adhesive material, double-sided tape, clamps
to clamp each pad to the skin and a strap for strapping each pad to the
skin.

33. The method according to claim 32, wherein the strap includes a spacer
placed beneath the pad between the strap and skin for concentrating a
skin attachment force at the pad.

34. The method according to claim 28, wherein the biomechanical properties
include any one or a combination of force-elongation characteristic, and
time-dependent force and strain characteristics.

35. The method according to claim 34, further including the steps of
measuring the applied force and corresponding induced movement in a
plurality of directions through a point, and determining two-dimensional
biomechanical properties at said point.

36. The method according to claim 35, wherein the two-dimensional
biomechanical properties include determining the direction of the
Langer's Line through said point.

37. The method according to claim 34, wherein the step of measuring is
repeated at a plurality of points, said plurality of points defining a
region, and further including the step of constructing a map of
biomechanical properties pertaining to said region.

38. A method for measuring in vivo natural length of skin, comprising the
steps of:attaching a first pad to the skin;attaching a second pad to the
skin, at a known distance from the first pad;attaching a third pad to the
skin, co-linear with a first axis connecting the first and second pad, so
as to place the first pad intermediate the second and third pad, said
pads attached to prevent relative movement between the respective pad and
the skin;applying a force to the first pad, along the first axis towards
the third pad, to induce relative movement between the pads to cause a
desired deformation of the skin between said pads, up to a pre-determined
physical limit, and measuring the applied force on reaching said
limit;releasing said force;re-attaching either or both said second and
third pads at a pre-determined distance closer to the first
pad;re-applying a force to the first pad, along the first axis towards
the third pad, to induce relative movement between the pads to a cause a
desired deformation of the skin between said pads, up to the
pre-determined limit,measuring the applied force on reaching said
limit;releasing said force; andrepeating a cycle of re-attaching,
reapplying, measuring and releasing until a specified criteria for the
measured forces is met, the natural length being equal to the distance
between the second and third pads when the specified criteria is met.

39. The method according to claim 38 wherein, during each cycle, only the
third pad is reattached and the pre-determined physical limit corresponds
to a known relative movement between the first and third pads.

40. The method according to claim 38 wherein, during each cycle, both the
second and third pads are reattached so as to maintain the first pad
equidistant between said second and third pads, and the pre-determined
physical limit corresponds to a known strain of the skin between said
first and third pads.

41. The method according to claim 38, wherein the specified criteria
includes the measured force for the last cycle being equal to or greater
than the measured force for the previous cycle.

42. The method according to claim 38, wherein the specified criteria
includes the measured force for the last cycle being equal to a
pre-determined minimum force.

43. A method for measuring in vivo natural tension of skin, comprising the
steps of:attaching a first pad to the skin;attaching a second pad to the
skin, at a known distance from the first pad, said pads attached to
prevent relative movement between the respective pad and the
skin;applying a force to the first pad, toward the second pad along a
first axis connecting the first and second pad, to induce corresponding
relative movement between the pads to cause deformation of the skin
between said pads, until the distance between the first and second pads
is equal to a natural length of the skin; andmeasuring the applied force,
the applied force being equal to the natural tension.

44. The method according to claim 43, wherein the natural length is
determined using a method comprising:attaching a first pad to the
skin;attaching a second pad to the skin, at a known distance from the
first pad;attaching a third pad to the skin, co-linear with a first axis
connecting the first and second pad, so as to place the first pad
intermediate the second and third pad, said pads attached to prevent
relative movement between the respective pad and the skin;applying a
force to the first pad, along the first axis towards the third pad, to
induce relative movement between the pads to cause a desired deformation
of the skin between said pads, up to a pre-determined physical limit, and
measuring the applied force on reaching said limit;releasing said
force;re-attaching either or both said second and third pads at a
pre-determined distance closer to the first pad;re-applying a force to
the first pad, along the first axis towards the third pad, to induce
relative movement between the pads to a cause a desired deformation of
the skin between said pads, up to the pre-determined limit;measuring the
applied force on reaching said limit;releasing said force; andrepeating a
cycle of re-attaching, reapplying, measuring and releasing until a
specified criteria for the measured forces is met, the natural length
being equal to the distance between the second and third pads when the
specified criteria is met.

Description:

FIELD OF INVENTION

[0001]The invention relates to measurement of biomechanical properties of
skin using a non-invasive approach.

BACKGROUND

[0002]Human skin provides the body with a flexible barrier to the exterior
environment through a highly integrated layered structure consisting of
epidermis, dermis and subcutaneous tissues. Each layer has its own
specific structure and functions. Mechanical behaviour of the human skin
is complex and well known to exhibit nonlinear and time-dependent
mechanical behaviour.

[0003]During skin flap/graft reconstruction surgery, surgeons need to
transplant a skin graft from a healthy area (i.e., the donor site) to the
trauma area (i.e., the recipient site). For a graft, surgeons need to
estimate the final shape of an excised flap from the donor site so that
it can fit the recipient site. When excised from a donor site, a flap
will shrink. The amount of shrinkage is highly sensitive to the
patient-specific skin structure,

[0004]As widely accepted, skin is biaxially stretched in one's body and
thus, one way of estimating the shrinkage is to determine the
un-stretched length/natural length (NL) of the skin at various
directions. At this stretched state, skin would have residual tension;
static and dynamic. The static tension is the built-in skin tension and
the dynamic tension is caused by forces from joint movements and other
voluntary muscle activity. Both are shown to contribute to skin flap
shrinkage. Therefore, in order to predict the patient specific skin flap
shrinkage, one would have to measure not only the biomechanical
properties but also the natural tension (NT) of a skin site of interest.
Some researchers have estimated the natural tension of a skin using a
pre-tension apparatus and a strain gauge and reported that the tension is
greater in the Langer's line direction. However, at present, there is no
commercial device available that will estimate these directionally
dependent NT and NL values.

[0005]The usual graft is a `flap`, a technical term including not only
skin but material from beneath it; including blood vessels that
microsurgery can connect to vessels at the recipient site. In the present
submission, we refer for brevity to this complex multilayer as `skin`.
From the standpoint of those wishing to measure the mechanical properties
of skin in the narrower sense (for example, in assessing the influence on
it of a skin cream), the in vivo mechanical effect of the underlying
layers is a problem. From a standpoint concerned with grafts, a
collective characterisation approximating the combined biomechanics of
the multiple layers in a flap is more useful.

[0006]A skin flap has two main layers (dermis and fat) with an artery and
a returning vein to provide nutrients and remove waste respectively. For
survival after grafting, the blood pressure inside the tissue should be
kept above a critical value (32 mm Hg). If the pressure falls below this,
blood supply will not be adequate and the transplanted flap will not
survive. Re-stretching the flap to the original size compresses its
incomplete arterial connections to a point where this fails, so the
surgeon has a complex problem of determining the excess amount of flap in
various directions to be harvested for a given recipient site, while
avoiding wastage.

[0007]At present, shrinkage estimation is based on the doctor's skill and
experience. A doctor will usually furnish an estimate based on a tactile
pinch on the patient's skin to estimate the tension and elasticity, on
the patient's physiology, on evaluation of the donor site, and on other
factors. For junior surgeons, flap/wound mismatch problems are frequent
due to judgment error, lack of quantitative tools, and inadequate
understanding of the mechanical behaviour of the skin. Such problems
often lead to further complications and trauma to the patient. Therefore,
in order to assist the surgeons during the critical stage of skin flap
planning, there is a need to develop an appropriate measurement device.

[0008]It is known that in the normal physiological state skin is strained.
This influences its biomechanical behaviour considerably. The influence
of mechanical forces on skin has been examined since 1861, when Langer
first reported the existence of lines of tension in skin, this work later
repeated by Cox. Cox's lines of tension did not match those of Langer,
but both reported the symmetrical nature of these lines of tension in the
biomechanical behaviour of human skin. These lines can only be defined by
microscopic techniques. In a section cut parallel with these lines, most
of the collagenous bundles of the reticular layer are cut longitudinally,
while in a section cut across the lines, the bundles are in cross
section. A line following the preferred orientation of fibres within the
dermal tissue is referred as a Langer's line in honour of Langer, whose
pioneering work led to their discovery.

[0009]These tension lines are of interest to the surgeon because an
incision made parallel to them heals with a finer scar. An incision
across them may set up irregular tensions that result in more noticeable
scarring. Furthermore, the shrinkage of excised flap shows a high
dependency on these lines of tension. Unfortunately, the directions of
Langer's lines are not constant between patients but show significant
variations, and may not remain constant at an anatomical site for a
specific subject. Langer's lines correspond closely with the crease lines
on the surface of the skin in most parts of the body. The precise
orientation of fibres defining such lines can only be found by
penetrative techniques. Because of their invasive nature, such techniques
are not widely applicable.

STATEMENT OF INVENTION

[0010]It is, therefore, an object of the present invention to provide a
non-invasive testing method for the measurement of biomechanical
properties, which in turn may be used to characterise the Langer's lines
and to predict skin flap shrinkage pre-operatively.

[0011]In a first aspect, the invention provides an assembly for measuring
in vivo biomechanical properties of skin, comprising a testing device,
said testing device comprising; a first pad attachable to the skin; a
second pad attachable to the skin, at a known distance from the first
pad; said attachability of the pads to the skin to prevent relative
movement between the respective pad and the skin to which it is attached;
a forcing means for applying a force to the first pad, whilst said pads
are attached to the skin, along a first axis connecting the first and
second pad, to induce a corresponding relative movement between the pads
due to deformation of the skin between said pads; a force measurement
device for measuring the applied force, and; a displacement measurement
device for measuring the corresponding induced movement.

[0012]In a second aspect, the invention provides an assembly for measuring
in vivo biomechanical properties of skin, comprising a testing device,
said testing device comprising; a first pad attachable to the skin; a
second pad attachable to the skin, at a known distance from the first
pad; said attachability of the pads to the skin to prevent relative
movement between the respective pad and the skin to which it is attached;
a forcing means for applying a force to the first pad, whilst said pads
are attached to the skin, along a first axis orthogonal to a second axis
connecting the first and second pad, to induce a corresponding relative
movement between the pads due to deformation of the skin between said
pads; a force measurement device for measuring the applied force, and; a
displacement measurement device for measuring the corresponding induced
movement.

[0013]The present invention may avoid the invasive approach of surgery, in
order to obtain the mechanical properties of the skin, by taking an
alternative non-invasive approach, through mere attachment of the
measurement device to the skin. Whilst a surgical approach may provide
additional information, it is unnecessary for the measurement problem
solved by the present invention.

[0014]It will be appreciated by the skilled addressee that the prevention
of relative movement between the skin and the pad is applicable within
the effective range of applied force and strain for which the device is
intended.

[0015]Further, the invention may also provide a more rapid means of
surveying a large area of the patient, and so provide a more complete map
through repeated measurements at several locations. This may not be
practical through a surgical approach, since surgery at one point
modifies strain and tensions at locations near it.

[0016]This invention will also provide a tool for surgeons who want to
predict the skin flap shrinkage pre-operatively. As such, the design of
the donor flap to be harvested to optimize the healing process and to
reduce the tension related scars can be carried out away from the
operative room.

[0017]In a preferred embodiment, the testing device may also include a
support bracket having the first pad slidingly mounted to the support
bracket, and the second pad fixedly mounted to the support bracket; such
that the first pad is slidingly movable parallel to the first axis.

[0018]In a more preferred embodiment the testing device may also include a
third pad attached to the skin and fixedly mounted to the support bracket
along the first axis, so as to place the first pad intermediate between
the second and third pad. The purpose of the third pad is to insulate the
measured skin between the first and second pads from external
disturbances. Thus, direct axial force may be applied, and a direct
force/elongation characteristic determined more accurately. Additional
pads mounted to the support bracket may be used as desired to provide
further stability during measurement.

[0019]In an alternative embodiment, the testing device may use a second
pad attached to the skin and fixedly mounted to the support bracket, such
that the second pad is spaced from the first pad along a second axis
orthogonal to the first axis. By a similar application of force, the
position of the second pad, initially level with the first pad may permit
measurement of the shear force/elongation characteristic of the skin.

[0020]In either embodiment, the testing device may be a unitary device
having the second and third pads fixed to the support bracket and the
first pad slidable to a desired position, or when attached to the skin,
be slidable to permit localised compression/extension of the skin in
order to take appropriate measurements.

[0021]This unitary structure may further permit easier reattachment for
facilitating multiple readings at multiple locations on the patient. The
support bracket may also provide a degree of stability to the testing
device during testing. The application of force may be offset from the
skin and so will apply a moment about the pads. The use of the support
bracket may resist this moment through a high tolerance engagement with
the pads, whereby rotational displacement is not permitted. Thus, in this
embodiment, any error in rotation or moment may be minimised or avoided.

[0022]In a further preferred embodiment, the forcing means may include a
constant strain rate actuator for selectively applying the force at a
pre-determined strain rate to the skin. The visco-elastic properties of
the skin may make it susceptible to an erroneous measurement through a
non-uniform application of strain. Further, to standardize measurement,
it may be necessary to apply strain at a constant rate, for example, at
0.35 mm/sec. The said actuator may further apply the force through a worm
gear, or other suitable high tolerance device to ensure accurate movement
of the force applicator.

[0023]In a more preferred embodiment, the control of the constant strain
rate actuator may be subject to a control system, automatically
controlling the application of force, and simultaneously recording the
force and displacement. This information may also be instantaneously
transcribed to a plotter, stored electronically to a file or both.

[0024]In a further preferred embodiment, the pads may be attached to the
skin using skin attachment means, said skin attachment means may include
any one or a combination of adhesive material, such as double-sided tape
or liquid adhesive, clamps to clamp each pad to the skin and a strap for
strapping each pad to the skin, attaching it by virtue of the tension in
the strap. For instance, the strap may be closed through Velcro®. It
may further include a spacer placed beneath the pad between the strap and
skin for concentrating a skin attachment force at the pad.

[0025]In a more preferred embodiment, the force may be measured by a load
cell. This load cell may further be located adjacent the skin in contact
with the pad, and preferably in contact with the skin attachment means.

[0026]An application of this testing device may include the determination
of biomechanical properties of the skin of a patient which may include
any one or a combination of linear and shear force-elongation
characteristics, and time-dependent force and elongation characteristics,
such as force relaxation and creep.

[0027]By taking a plurality of measurements of applied force and
corresponding induced movement at a plurality of locations,
two-dimensional biomechanical properties may be determined, which may
include determining the direction of the Langer's Line, biomechanical
properties to determine skin flap shrinkage, natural tension and natural
length measurements.

[0028]In a preferred embodiment the fixed mounting of the second and third
pad to the support bracket may be selectively adjustable to permit
sliding movement of said pads.

[0029]It should be noted that the sources of error may include the
inconsistent pressure with which testing device may press onto the skin
at the pads, and the handling means used by the operator. Therefore, in a
preferred embodiment, the assembly may also include a positioning
assembly having an engagement portion for engaging an external body and a
holding portion for holding the testing device, said positioning assembly
adapted to apply a constant and consistent pressure of the pads on the
skin at a specified force.

[0030]In a preferred embodiment the holding portion may have a selective
sliding engagement with the testing device. Also, the positioning
assembly may be selectively deformable for positioning the testing device
relative to the skin.

[0031]In a more preferred embodiment the holding portion may include a
load measurement device to measure the component of force applied at
right angles to the skin by the testing device. The load measurement
device may also measure the applied torque in order to make sure the pads
apply even pressure onto the skin.

[0032]In a third aspect, the invention provides a method for measuring in
vivo biomechanical properties of skin, comprising the steps of attaching
a first pad to the skin; attaching a second pad to the skin, at a known
distance from the first pad, said pads attached to prevent relative
movement between the respective pad and the skin; applying a force to the
first pad, along a first axis connecting the first and second pad, to
induce corresponding relative movement between the pads due to
deformation of the skin between said pads; measuring the applied force,
and; measuring the corresponding induced movement.

[0033]In a preferred embodiment the method may include measuring the
applied force and the corresponding induced movement in a plurality of
directions for the same region of skin, and determining two dimensional
biomechanical properties based on measurements in the plurality of
directions. In a most preferred embodiment, this may provide sufficient
information to determine the direction of the Langer's Line in the said
region of skin and other necessary biomechanical properties and natural
tension measurements to estimate skin flap shrinkage.

[0034]In a fourth aspect, the invention provides a method for measuring in
vivo natural length of skin, comprising the steps of: attaching a first
pad to the skin, attaching a second pad to the skin, at a known distance
from the first pad, attaching a third pad to the skin, co-linear with a
first axis connecting the first and second pad, so as to place the first
pad intermediate the second and third pad; said pads attached to prevent
relative movement between the respective pad and the skin; applying a
force to the first pad, along the first axis towards the third pad, to
induce relative movement between the pads to cause a desired deformation
of the skin between said pads, up to a pre-determined physical limit, and
measuring the applied force on reaching said limit; releasing said force;
re-attaching either or both said second and third pads at a
pre-determined distance closer to the first pad; re-applying a force to
the first pad, along the first axis towards the third pad, to induce
relative movement between the pads to a cause a desired deformation of
the skin between said pads, up to the pre-determined limit, and measuring
the applied force on reaching said limit; releasing said force; repeating
a cycle of re-attaching, reapplying, measuring and releasing until a
specified criteria for the measured forces is met, the natural length
being equal to the distance between the second and third pads when the
specified criteria is met.

[0035]In a fifth aspect, the invention provides a method for measuring in
vivo natural tension of skin, comprising the steps of attaching a first
pad to the skin, attaching a second pad to the skin, at a known distance
from the first pad, said pads attached to prevent relative movement
between the respective pad and the skin; applying a force to the first
pad, toward the second pad along a first axis connecting the first and
second pad, to induce corresponding relative movement between the pads to
cause deformation of the skin between said pads, until the distance
between the first and second pads is equal to a natural length of the
skin; measuring the applied force, the applied force being equal to the
natural tension.

BRIEF DESCRIPTION OF THE DRAWINGS

[0036]It will be convenient to further describe the present invention with
respect to the accompanying drawings which illustrate possible
arrangements of the invention. Other arrangements of the invention are
possible, and consequently the particularity of the accompanying drawings
is not to be understood as superseding the generality of the preceding
description of the invention.

[0037]FIG. 1 is a graphical representation used for locating the Langer's
Line;

[0038]FIG. 2 is a representation of one approach used for identifying the
ellipse of FIG. 1;

[0039]FIG. 3 is an isometric view of one embodiment according to the
present invention;

[0040]FIGS. 4(a) and (b) are views of a second embodiment according to the
present invention;

[0041]FIG. 5 is an isometric view of a third embodiment according to the
present invention;

[0042]FIG. 6 is an isometric view of a fourth embodiment according to the
present invention;

[0043]FIG. 7 is an isometric view of a fifth embodiment according to the
present invention;

[0044]FIGS. 8(a) and (b) are schematic views of the load distribution of
the skin according to the present invention;

[0045]FIGS. 9(a) and (b) are plan views of a sixth embodiment of the
present invention;

[0046]FIGS. 10(a) to (d) are sequential views of a method according to a
further embodiment of the present invention;

[0047]FIGS. 11(a) to (d) are sequential views of a method according to a
further embodiment of the present invention;

[0048]FIGS. 12(a) and (b) are experimental results from conducting the
methods of FIGS. 10 and 11, and;

[0049]FIGS. 13(a) and (b) are sequential views of a method according to a
further embodiment of the present invention.

DESCRIPTION OF PREFERRED EMBODIMENT

[0050]It has been reported that the load in the high modulus region is
primarily due to the stretching of collagen fibres, drawn tight, whereas
deformation of the elastin network governs behaviour in the low modulus
region/initial phase, where a typical collagen molecule is sufficiently
slack to represent little resistance to skin stretching. Therefore, by
studying the high modulus region of the force-elongation curve, it is
possible to attain information on the collagen structure.

[0051]When the moduli of the high stiffness region of the stress-strain
curves through a fixed point in various orientations are plotted in polar
co-ordinates, the graph of mechanical properties with respect to testing
direction is periodic. It is clear from FIG. 1 that these points join to
form an ellipse shape 1.

[0052]These results substantiate the hypothesis that Langer's line 5 is
the preferred orientation of the fibres within the reticular dermal
tissue. The results as shown in FIG. 1 demonstrate that the direction of
a local Langer's line 5 can be positively determined by multiple
force-elongation tests. However, obtaining a complete set of
load-extension curves in many directions is extremely time consuming.

[0053]FIG. 2 shows the effect of limiting the number of such tests. In
order to minimize the number of tests needed, a mathematical procedure
may be adopted formulated using only 3 points F1, F2 & F3. It is
hypothesized that the 3 data points will follow an ellipse 10. In order
to find the equation of an ellipse that will best fit the 3 data points,
all the calculations are performed in polar co-ordinates and the equation
of the ellipse is given as follows:

F 2 cos 2 θ a 2 + F 2 sin 2 θ b
2 = 1 ( 1 ) [0054]where a=Major axis of the ellipse
[0055]b=Minor axis of the ellipse [0056]θ=angle between any point
on the ellipse and the major axis

[0057]The first data point F1 at 0° is taken approximately along
the direction of the skin's crease lines (which are known to be close to
the Langer's line), and so this magnitude will be larger than F2 and F3.
Therefore, it is expected that the major axis of ellipse to lie close to
this point, and hence the value of θ is expected to be small. By
choosing a 45° sampling interval, one can ensure that the three
data points will cover as much of one quadrant of the ellipse as possible
for a high fitting accuracy. Alternatively, one may choose three lines at
60° angles, so that three data points will span at least two
quadrants. Equation (2) can be obtained by substituting the test data to
F1, F2, F3 and the angle into equation (1). Subsequently, a numerical
solution can be found that will best satisfy equation (2).

[0058]The fitting error is calculated by taking θ to be accurate and
finding the difference between the experimental data and the data on the
ellipse at the same angle. The largest error among the three data points
is taken as the fitting error.

[0059]Therefore, this ideal method of assessing the direction of the local
Langer's line is to use the testing device to produce load-extension
dataset at three different directions, at 45° or 60° each
other. Then by using the mathematical principle indicated by equation
(2), the polar equation of prospective ellipse is solved numerically. The
direction of the Langer's line will correspond to the direction of the
major axis of the ellipse.

[0060]Alternatively, the ellipse may be considered (relative to any
convenient system of axes, such as any two orthogonal directions or the
directions of two of the measurements) as represented by an equation of
the form

ax2+2bxy+cy2=1. (3)

[0061]The extension due to unit force in the direction of a vector (X,Y)
with X2+Y2=1 (that is, a unit vector) is then inversely
proportional to ax2+2bxy+cy2, since a large radius of (3) in
that direction corresponds to a small value of aX2+2bXY+cY2.
Given such extensions E1, E2 and E3 in the respective
directions of three vectors (X1,Y1), (X2,Y2) and
(X3,Y3), we thus have

aX12+2bX1Y1+cY12=(1/E1)

aX22+2bX2Y2+cY22=(1/E2)

aX32+2bX3Y3+cY32=(1/E3)

a linear problem in the three coefficients a, b and c. This has the
solution

well defined if the three directions are distinct, and most robust if they
are well separated. The Langer line through the current point is then the
eigenline belonging to the smaller eigenvalue

λ = a + c - ( a - c ) 2 + b 2 2 ;

that is, the line

(a-λ)x+by=0,

or equivalently

bx+(c-λ)y=0.

[0062]Many alternative mathematical formulations will be recognized as
equivalent to these by one skilled in the art.

[0063]Therefore, in order to achieve the aforementioned results, a testing
device 18 according to one embodiment of the invention is shown in FIG.
3. Three pads 20, 25 and 30 are attached to the skin of the patient. Two
of the pads are fixed spatially to a bracket 60, with the third pad 30 in
sliding engagement with said bracket 60. A servomotor 50 acts upon a worm
gear 45 to apply a force to the slidable pad 30 to either bias it towards
the distal pad 20 or the proximate pad 25. Recording of the applied force
is measured through load cell 35, and in this embodiment electronically
recorded (not shown).

[0064]Displacement may be measured through a displacement transducer. Thus
a log of the application of force against displacement or time during the
extension or compression 40 of the skin can be recorded. A preferred
applied maximum strain of 50% may be adopted, to avoid patient
discomfort, and also to ensure the integrity of the attachment means of
the pads to the skin.

[0065]FIG. 4(a) shows an alternative arrangement of the testing device 65.
Here the distal pad 70 is positioned at right angle to the application of
force 80. Thus the slidable pad 75 will tend to stretch the skin to
produce a shear effect, as shown in FIG. 4(b).

[0066]Whereas a plot of the results of the arrangement in FIG. 3 would
provide a direct characterisation of the relation between elongation and
tension, the equivalent plot of force against positionally imposed strain
for the arrangement of FIG. 4(a) would yield a characterisation of the
relation between elongation and shear, again adding to the range of
biomechanical properties offered by embodiments of the testing device of
the present invention.

[0067]FIG. 5 shows an alternative arrangement 85 to the direct force
application device of FIG. 3. Here, the servomotor 100 is placed above
the gear 45, with the drive provided through a belt, or chain drive
arrangement 90, 95. As with the arrangement of FIG. 3, the slidable pad
is biased 40 towards the proximate pad 25, for direct force/elongation
measurement.

[0068]FIG. 6 shows an additional attachment to the overall assembly,
whereby the testing device 18 is mounted to a positioning assembly 105.
This positioning assembly 105 includes a bracket or platform 108 which
may be attached to a stable external location, and a flexible articulated
arm 110. At the distal end of the arm 110 is a holding arrangement 118,
whereby the testing device 18 can be supported in a sliding 120
arrangement through slide 115. A further extension arm 119 is then used
to offset the testing device 18 from the positioning assembly 105.

[0069]Thus, the positioning assembly 105 can position the testing device
18 in any number of arrangements without the human operator handling the
device. The slide 115 enables the device 18 to rest horizontally on the
skin 125 at its own weight, thereby standardizing the pressure that the
pads 20, 25 and 30 presses onto the skin. This standardization and
non-operator handling enable consistent and reproducible measurements to
be taken.

[0070]FIG. 7 shows a further arrangement of the positioning assembly 105,
whereby the holding arrangement 118 of FIG. 6 is replaced with a holding
engagement 135.

[0071]The testing device 18 will preferably press onto the skin at a
standard force during measurement. Otherwise, the readings may vary
between samples. If the pressure is very high, then the skin beneath the
pads will be overly compressed. This may cause the skin between the pads
to push outward and affect the measurement. In addition, the load cell
will also register an offset reading and contribute further to the error.
Lastly, compressing the skin will cause the biological structures inside
to press together and this will affect the mechanical behaviour.
Conversely, if the pressure is very small such that the pad just lightly
touches the skin, the skin attachment means may detach easily after a
small strain. It follows that readings may be affected by the pressure on
the skin, and different handling procedures of the operator. Therefore,
standardization is very attractive for consistent and reproducible
measurement results over time and between different operators.

[0072]In a further preferred embodiment, the load cell may also measure
torque to make sure that all the pads press onto the skin at the same
force; if there is any unevenness, a resultant torque will be registered.
Alternatively, load cells placed beneath each pad may be used to detect a
differential in pressure between the pads, and subsequently used to
balance the pressures. The operator will press the device into the skin
until a specified force and torque are registered at the load cell meter
140. Then measurement will start. This configuration enables the device
to be placed at any angle to the surface.

[0073]In a further embodiment, different size pads may be used to minimize
the "edge effect" during an in vivo experiment. It is suggested that
increasing the "aspect ratio" (between the pad width and the distance
between the pads) may reduce differences between in vivo and in vitro
data. Thus, by selecting pads having a practically large aspect ratio,
such as 2.5, the error contribution due to the surrounding materials in
an in-vivo measurements environment may be minimized. Thus, attained
results will be closer to the true characteristics of the materials, as
measured in vitro (though some measurement such as shear response may
become more difficult). This will permit comparison and normalization of
data acquired with the present invention, against data acquired by the
use of previously standard devices.

[0074]The following discussion makes reference to FIGS. 8(a) and (b). In
an in-vitro measurement, the stress-strain property of a material can be
accurately measured because the test sample is prepared to the
appropriate size such that the grippers of the tensile tester cover the
sample completely. Therefore, during pulling, the tension lines
(principal directions of the stress tensor, for the larger eigenvalues)
in the material are all aligned in the direction of applied force.

[0075]On the other hand, in an in-vivo measurement, as the pads (acting as
grippers) move apart during measurement, the adjoining material is also
deformed. Therefore, there will be additional tensor contributions from
the adjoining material, and the measurement will not fully represent the
stress-strain properties of the material between the pads.

[0076]The stress-strain data from an in-vivo test will have a higher
magnitude compared to an in-vitro test. This is a problem for all in-vivo
testers, such as extensometers.

[0077]In one embodiment, the width of the pads may be large with respect
to the separation between the pads. Increasing the aspect ratio (ratio of
a pad's width to the pads' separation) may reduce the error between the
stress-strain results obtained from in-vivo tests as compared to standard
in-vitro tests.

[0078]With a large aspect ratio, during stretching, the tensor components
170 between the legs 165a,b are dominant compared to those contributing
from the sides 180. The influence from the side tensors 180 becomes
relatively minimal, and the measurement will be closer to the actual
stress-strain between the pads. Therefore, the measured data will be
closer to in-vitro data.

[0079]This can also be explained mathematically. Assume a situation where
the width of the wide pads 165a,b (large aspect ratio configuration) is 4
times larger than the small pads 160a,b.

[0080]Let FL=Force contribution from linear tensors 175 between the small
pads 160a,b

[0081]Then the force from the principal tensor components 170 between the
wide pads=4FL

[0082]Let FS1=Force contribution from the lateral tensor components
185 at the small pad due to stretching of the adjoining material

[0083]Let FS2=Force contribution from the lateral tensor components
180 at the wide pad due to stretching of the adjoining material

is the error term for σWide. Since both the small and wide pads
are surrounded by adjoining material which will stretch together, the
lateral tensor components at both pads will be close. Therefore, we can
assume that FS1≈FS2.

[0089]Hence,

F S 2 4 W

is approximately 4 times smaller than

F S 1 W .

[0090]And so, σWide is much closer to σIn-vitro than
to σSmall.

[0091]In general, as the width of the wide pad increases, the error term
will reduce and the result will gradually converge towards the in-vitro
result. Therefore, the measurement will be more accurate.

[0092]Alternative arrangements for the pads are shown in FIGS. 9(a) and
9(b). Here the concept of the "shield pad" is introduced. In the first
embodiment, the pad arrangement 190 includes the stationary pad 195
according to the previous embodiments. Further included are peripheral
pads 205a,b, which act as "shield pads to the sensor pad 200.

[0093]A typical extensometer has 2 pads (attached to the skin) that move
apart during measurement. In this arrangement 190, forces measured in
in-vivo are always higher than in-vitro ones for the same extension. In
an in-vitro measurement, the material is excised and prepared such that
the width is the same/smaller as that of the pads or grippers.

[0094]In in vivo measurements, the force measured is higher because the
surrounding material is stretched together with the material between the
pads. FIG. 9(a) shows simplified tensor lines 210, 215 to illustrate what
goes on in an in-vivo measurement.

[0095]Since the desired data is the mechanical property of the skin 210
between the pads 210 and 195, the contributions due to 215 are
undesirable. Furthermore, the "in-vitro" data is needed because:
[0096]1. Finite element modelling requires true material properties to
simulate skin flap shrinkage. [0097]2. In order to find true NL, elastic
modulus and NT of skin [0098]3. In-vitro data reflects the true uniaxial
properties of the skin in the measured direction. If the measured data is
influenced by the properties of skin in the other directions, then data
interpretation is more difficult.

[0099]To the right of this arrangement, the upper peripheral pad 205a and
lower peripheral pad 205b sandwich the sensor pad, which contains the
load cell. These peripheral pads 205a,b effectively shield the sensor pad
from the surrounding forces, and the load cell is mainly subjected to the
forces 210 between pad 195 and pad 200. Therefore, the results measured
will be much closer to the in-vitro result.

[0100]In an alternative embodiment of the "shield pad" concept, to further
isolate the load cell from external forces, a C-pad 225 may be used for a
complete shielding of the sensor pad 235, as shown in FIG. 9(b).

[0101]FIGS. 10 to 12 show a methodology to find the NL of skin in-vivo
using the extensometer according to an aspect of the present invention.

[0102]In one embodiment of the methodology, FIGS. 10(a) to 10(d) shows a
four stage process. Here, two large side pads 250, 255 are attached to
the skin 252 while a load cell pad 260 measures the force at a specified
extension (xo) from a fixed distance (d) from the left pad. In this
embodiment, for a distance between the pads 250, 255 of 60 mm, the fixed
distance (d) may be in the range 10 to 30 mm, and the specified extension
(xo) being in 10 mm. At stage 1, shown in FIG. 10(a), the force
F1 will be highest. As the side pads 250, 255 move together (denoted
by xs) at stage 2, as shown in FIG. 10(b), the skin 253 in between
will be slightly relaxed. Therefore, the force measured (F2) at the
same position (d) and same extension xo will be lower. It should be
noted that the incremental movement of the pads (xs) may be about 1
mm.

[0103]When the pads 250, 255 move to stage 3, as shown in FIG. 10(c), the
skin 254 in between reaches the natural length and will be completely
relaxed. Hence, the force measured F3 will ideally reach the lowest
value. At any subsequent distances (xs), the force measured will
remain at the same value (F4=F3). On the other hand, if the
skin 256 goes into compression, as shown in FIG. 10(d), after reaching
the natural length, then the force measured will be higher
(F4a>F3) 335.

[0104]As shown in FIG. 12(a), in either of the cases above, a transition
point 330 where the curve 310 goes flat 340 will be observed, with that
transition point 330 corresponding to the natural length position. In
certain circumstances, the curve may not become horizontal as expected,
but the gradient may fall to a low value near zero, F4b 345. The
transition point may be taken as the point where the gradient falls to a
specified threshold.

[0105]Following the methodology of FIGS. 10(a) to (d), it may be necessary
to remove the load cell pad 260 every time the side pads are moved
together (xs). If the load cell pad 260 remains attached to the skin
at distance (d) while the right pad is moved closer, the skin on both
sides of the load cell pad may be unevenly distributed. In this case, the
result may not be sufficiently accurate.

[0106]Further, the skin may wrinkle unevenly between the side pads 250,
255, with the skin nearer to the side pad 250 folding more than that near
the middle.

[0107]This uneven wrinkling may create a problem for the force measurement
at the load cell pad 260, unless it is always kept at the centre of the
side pads 250, 255 so that the skin is evenly distributed on the left and
right. However, since the load cell pad must be kept at a standard
distance (d) from one side, the uneven wrinkling may cause the force
measurement to be inaccurate.

[0108]A solution is demonstrated in the further embodiment shown by the
methodology of FIGS. 11(a) to (d). Here the object is to think in terms
of strain. This is done by keeping the load cell pad always at the
centre, and to plot the result for force at the same strain (ε),
possibly in the range 5% to 100%, instead of force at the same extension.
As shown in FIGS. 11(a) to (d), the distances d1 to d4 may be in the
range 10 to 30 mm for a pad separation of 60 mm.

[0109]The expected result is illustrated in FIG. 12(b), where the force at
a specified strain (ε) for each curve is plotted against xs
350, where xs may be in 1 mm increments, as with the method shown in
FIGS. 10(a) to (d). Instead of force, the energy (per unit length) of
each curve at the specified strain may also be plotted 355. This energy
is found by computing the area under the curves (up to the specified
strain). In practice, the energy is a better parameter than force because
this parameter is less subjected to measurement noise.

[0110]The problems caused by automation difficulty and uneven skin
wrinkling may be solved in this alternative method, should the greater
degree of accuracy be required. By keeping the load cell pad always at
the centre, the distribution of skin to its left and right is always
even. Therefore, the force measurement is accurate. Furthermore, there is
no need to remove the load cell pad at every retraction of the side pads,
thus making automation easy.

[0111]In a further embodiment, a method according to the present invention
may be adopted to measure the NT, Elastic Modulus and NL of the skin
using the "shield pad" embodiments, as shown in FIGS. 13(a) and (b). As
mentioned earlier, the "shield pad" embodiments effectively reduce the
force measured to one dimension.

[0112]The force measured by the extensometer is the difference between the
skin tension on the left (F1) and right (F2) of the load cell
360, i.e. F2-F1. When the extensometer is first attached to the
skin 362, the load cell pad 360 reads no force since the natural tension
(To) on the right cancels the natural tension on the left. A
separation of the pads 360, 365 in the normal, unstressed position may be
approximately 25 mm.

[0113]As the load cell pad 360 is moved to the left towards the stationary
pad 365, to compress the skin 367, the tension F1 will gradually
decrease in the typical J-profile. On the other hand, the tension F2
will remain approximately constant if the skin 367 is "infinitely" long
on the right hand side. This is a reasonable assumption because the
displacement applied is small compared to the much larger skin surface.
If there are concerns that F2 may not remain constant during the
compression, the C-pad shield 225, in particular, can be used to solve
this problem.

[0114]When the load cell pad 360 reaches a position where the skin 367 in
between the pads 360, 365 is at the natural length (NL). At this
position, the tension F1 is zero while F2 remains at the
natural tension To. Therefore, the load cell will read the natural
tension.

[0115]As the pad separation is further reduced, the skin in the middle
undergoes compression. At this stage, three different cases may happen to
the force-elongation reading (see FIG. 14). In the first case 368, the
change in force becomes smaller with displacement, as the skin relaxes
and folds gently upwards. In the second case 369, the change in force
continues to increase linearly with displacement along the original
curve. In the third case 370, the change in force becomes even greater
with displacement, as the skin folds and squeezes together. Note that as
more skin is being squeezed together, the force measured will eventually
increase greatly and curve downwards because the skin tissue will squeeze
tightly against each other.

[0116]In the first and second cases 368 and 370 above, the
force-displacement curve changes direction from the initial straight
line. In these cases, the transition point 371, which corresponds to the
natural length, can be identified clearly. For the second case 369, the
natural length will be overestimated, but it has been shown
experimentally that this case is relatively rare.

[0117]When the natural length 371 is determined from above, the true
origin 372 of the force-elongation behaviour of skin can be located (see
FIG. 15). From here, the natural tension 373 can be deduced directly,
while the gradient of the straight line 374 is the elastic modulus of the
skin at the first phase.